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CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer


Inclusion Criteria:



- Age > or = 18 years

- Social Insurance

- Performance Index <2

- Life expectancy> 6 months

- adenocarcinoma colorectal (histologically proven)

- Metastases (inoperable or recurrent after surgery),

- hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if
the two bodies are metastatic). The largest diameter of the metastasis will < ou =
6cm for the liver, < or = 6 cm for the lung. If multiple metastases, the sum of
their maximum diameter is 6cm < ou = the liver, < ou = 6 cm for the lung.

- Lesion (s) measurable (s) and evaluable (s)

- CT less than 3 weeks

- Patients must have received at least one prior chemotherapy regimen containing 5FU

• Patients may have received one or more lines of chemotherapy including irinotecan.

- bilirubin <1.5 x ULN

- AST and ALT <5x ULN

- neutrophils> 1.5x109 / L, platelets> 100x109 / L, hemoglobin> 9 g / dL

- TP, TCA Normal (only for patients treated with a permanent implant)

- Informed consent signed.

Exclusion Criteria:

- contraindication to the administration of irinotecan.

- History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.

- History of other invasive cancer treated in a period of less than 5 years (basal cell
carcinoma and non-invasive cervical excepted)

- Metastatic disease diffuse or more than three metastases in the liver and / or lung
during the natural history of disease (excluding any patient is having a complete
radiological response on several metastases although 1-3 residual after treatment (
s) medical (at)).

- Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the
cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and
left pulmonary arteries and right and left.

- Pregnancy or breastfeeding.

- Lack of means or refusal to use effective contraception for men or women of
childbearing age.

- Any other concomitant experimental treatment.

- Any other concurrent anticancer therapy, immunotherapy or hormonal therapy.

- Monitoring impossible because of psychological, sociological or because of
geographical distance.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

tumor response accoording to recist criteria

Outcome Time Frame:

5 years

Safety Issue:

Yes

Authority:

France : Afssaps

Study ID:

06/9-R

NCT ID:

NCT01220063

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • RSHF
  • Irinotecan
  • Colorectal Cancer
  • metastases
  • Colorectal Neoplasms

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